Devices

Olympus Gains Clearance on Modified Duodenoscope

FDA has cleared an Olympus 510(k) for the TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. The company intends to recall its original model currently being used in health care facilities and make the needed repair as quickly as possible, an agency news release says.

“Olympus modified its design of the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel,” FDA says. “Leakage into this channel could pose an infection risk to subsequent patients exposed to the contaminated device because the sealed area cannot be cleaned and disinfected between uses.” The company also plans to perform annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of any debris at the scope’s tip, which would require replacement of the potentially contaminated parts.

The clearance follows a 2014 request from FDA for Olympus to obtain 510(k) clearance for the “closed” elevator channel model, which had never been cleared for marketing. In a letter sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a “closed” elevator channel rather than an “open” elevator channel, were significant and impacted the safe use of the device.

FDA says the recall of existing devices will replace the elevator channel sealing mechanism at the tip of the scope with a new sealing mechanism. Olympus estimates it will be able to correct the mechanism in about 4,400 TJF-Q180V models currently used in health care facilities by August. “While awaiting repair, health care facilities may continue to use the Olympus TJF-Q180V, but they‎ should meticulously follow the manufacturer’s reprocessing instructions,” the agency says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome